Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04837638
Other study ID # FH-CAC (MP-20-2021-5767)
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overarching objective is to evaluate the relationship between diet and coronary artery calcification in patients with heterozygous familial hypercholesterolemia (HeFH). We will recruit adults with HeFH. They will have to complete questionnaires on diet, medication and lifestyle. Coronary artery calcification will be measured in each patient using a CT scan. Physiological and biochemical data will be collected.


Description:

The proposed research will deploy as cross-sectional study including treated adults with genetically-defined HeFH. Once recruited, participants will be asked to complete web-based questionnaires on diet, medication and lifestyle. They will thereafter complete a clinical assessment at the Clinical Investigation Unit of the NUTRISS-INAF Research Centre. Study staff will measure participants' height, weight, and waist circumference. Participants' blood pressure will be measured using an automatic blood pressure monitor (BP Thru, Omron) after sitting quietly for 10 minutes. Three sequential readings will be taken with three minutes between readings. Fasting blood samples (10 mL) will be collected from an antecubital vein. Body composition will be assessed with dual-energy X-ray absorptiometry (DEXA). Finally, participants will be asked to provide the full list of medication they are using, including type, dose and duration of use. Later on the same day, participants will undergo the non-contrast CT scan at the Quebec Heart and Lung Institute. Multidetector CT scans without contrast will be performed using a 256 slices helical scanner (Brilliance iCT, Philips).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 258
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Genetically-defined heterozygous familial hypercholesterolemia Exclusion criteria: - Homozygous FH - Personal history of cardiovascular disease - Personal history of cancer

Study Design


Intervention

Behavioral:
Diet
No intervention. Cross-section assessment of the relationship between diet, medication, lifestyle and coronary artery calcification.

Locations

Country Name City State
Canada Institute of nutrition and functional foods, Laval University Québec

Sponsors (3)

Lead Sponsor Collaborator
Laval University Centre de Recheche du Centre Hospitalier Université Laval, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relationship between diet quality and coronary artery calcification (CAC) Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. CAC will be measured using non-constrat CT scan. CAC scores will be quantified with the Agatston scoring method. Higher CAC scores reflect higher CAC. Diet questionnaire completion and CAC measurement will be completed with a 3 weeks period.
Secondary Relationship between diet quality and LDL-cholesterol. Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. LDL-cholesterol will be measured using standard procedures from the fasting blood sample collected on the same day of the CT-scan. Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.
Secondary Relationship between diet quality and Lipoprotein (a). Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. Lipoprotein (a) will be measured using standard procedures from the fasting blood sample collected on the same day of the CT-scan. Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.
Secondary Relationship between diet quality and intuitive eating. Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. Intuitive eating will be measured using the Intuitive Eating Scale. Diet questionnaire completion and psychological aspects of eating measurement will be completed with a 3 weeks period.
Secondary Relationship between diet quality and physical activity Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Physical activity will be assessed using the Godin physical activity questionnaire. Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Secondary Relationship between diet quality and sleep. Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Sleep will be assessed using the Pittsburgh Sleep Quality Index. Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Secondary Relationship between diet quality and substance use. Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). substance use will be assessed in a self-reported fashion using a questionnaire. Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Secondary Relationship between diet quality and alcohol consumption. Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Alcohol consumption will be assessed from the food frequency questionnaire. Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Secondary Relationship between diet quality and medication adherence. Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Medication adherence will be assessed using the Medication Adherence Report Scale. Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Completed NCT04025099 - Internal Cues Versus External Cues for Eating and Activity N/A
Completed NCT04766528 - Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity N/A
Completed NCT03277040 - Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives N/A
Active, not recruiting NCT05544461 - Piloting a Web-based Personalised Nutrition App (eNutri) With UK University Students N/A
Active, not recruiting NCT04748835 - The SEEA (SCI Energy Expenditure and Activity) Study
Active, not recruiting NCT04991142 - Models of Nutrition From Continuous Glucose Monitors
Recruiting NCT04487015 - A Digital Approach to Improving Carbohydrate Periodisation Behaviours in Athlete: SMART+ Study N/A
Completed NCT03748056 - Targeted Food Incentives to Improve Diet Quality and Health Among Adults N/A
Not yet recruiting NCT05960396 - Exploring the Mechanism of Dietary Pattern Improving MAFLD N/A
Enrolling by invitation NCT04314882 - The Danish National Survey of Diet and Physical Activity 2021-2023
Terminated NCT04677322 - TO ASSESS THE EFFECTIVENESS OF THE INTERVENTION OF THE LOW-SODIUM DIET IN PATIENTS WITH HTA
Completed NCT03855098 - Biomarkers of Food Intake Using a Cross-over Feeding Study N/A
Completed NCT03124446 - Mindfulness-Based College: Stage 1 N/A
Completed NCT03993652 - Kids FIRST: Family-based Intervention to Reduce Snacking and Screen Time in Children N/A
Completed NCT04766034 - Impact of Behavioral Economic Strategies on Low-Income Older Adults' Food Choices in Online Retail Settings N/A
Completed NCT03913871 - Text Message Program to Improve Eating Behaviors Among African Americans in New Orleans N/A
Completed NCT03698123 - Performance Nutrition for Residents and Fellows N/A
Completed NCT03941392 - Nutritional Study in Spanish Pediatric Population
Completed NCT03400566 - Effects of Experiential Learning on Vegetable Intake in Preschool Children N/A